Although the decision to class CBD as a Novel Food has not been universally welcomed, this FSA update provides much needed clarity for businesses and ultimately puts an end to thirteen months uncertainty for manufacturers and retailers.
CBD as a Food Supplement
We have known since January 2019 that a Novel food process would have to be undertaken, the question was just when, and whether products could continue to be sold. This created a conundrum for the FSA as it is one of the first products which has been sold extensively across the EU for several years before being declared as novel. The FSA therefore has had to balance the need to asses safety as part of a novel food authorisation against the fact that CBD supplements have been consumed extensively over the last few years.
In January 2019, the European Food Safety Authority (EFSA) determined that CBD oil was a novel food and it was added to the Novel Food Catalogue. While the catalogue is utilised by member states for assistance in Novel Food Regulation, it has no official legal status, meaning that the individual enforcement approaches differ for each state.
Regulations regarding the safety of food and drink products in the UK is determined and implemented by the Food Standards Agency (FSA). The FSA confirmed in early 2019 that it would follow the EU Commission's determination and industry has been keenly waiting for an update on the practical implications since then. On 13 February 2020 The FSA said that oils, snacks and drinks containing CBD will be “taken off the shelves” if they haven't submitted a valid application for regulatory approval by 31 March 2021.
Steps to take now
- Ensure products are correctly labelled, safe to eat and do not contain substances that fall under drugs legislation
- Check your formulation, the FSA now recommends no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction
- Ensure marketing communications don't imply that CBD products should be consumed by people who are pregnant, breastfeeding or taking any medication
- Prepare your novel food application
- Retailers will require proof that an authorisation has been applied for if they intend to continue to stock such products.
When importing, remember legal requirements will be different in other jurisdictions. There will be differences in labelling formats and the legality of the flavourings and colourings used. It will be important to consider which plants the CBD has been sourced from and whether these are approved by the country that the products are being imported to. Levels of THC will also be under scrutiny, with import licenses – which could take several months to obtain - likely to be required for detectable amounts. Failure to acquire relevant licenses may result in hefty fines.
What do businesses need to do by March 2021 to ensure they gain regulatory approval?
There is enough time to submit an application and it's important to note the FSA are not requiring the application be approved by 31 March 2021, but that there has been a valid submission by the date.
It's worth noting that the Committee on Toxicity, found evidence of potential adverse health effects from the consumption of these products and highlighted the lack of information in relation to risk - so dossiers will need to contain robust substantiation regarding the safety of the product in question.
The good news for businesses is that it does not appear that the Committee found evidence of risk to the general population and the FSA has stated that products can continue to be sold after 31 March 2021 if they have submitted a valid application to the FSA. The FSA has not made any promises as to time frames for approving applications.
Novel food applications require an applicant to provide a dossier of information to be submitted to the European Commission through an electronic portal - applications typically take months, if not years to be processed. Authorisation requires a great deal of scientific information and trials, which are time consuming and very expensive - which will push many SME manufactures out of this area.
But what about Brexit?
The UK has left the EU and the FSA has set a post-transition period deadline, so it will be interesting to see what a 'valid application' looks like after 31 January 2021.
Here are a few key points to be aware of:
- Industry has until 31 March 2021 to submit novel food applications
- In the interim products may remain on the market provided they are correctly labelled, safe to eat and do not contain substances that fall under drugs legislation
- After 31 March 2021 only products which have submitted a valid application will be able to remain on the market
- The FSA advises those who are pregnant, breastfeeding or taking any medication not to consume CBD products
- The agency recommends no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction
If you have any questions or require advice on CBD products and your business please contact Head of Retail, Food & Hospitality Hilary Ross or Dominic Watkins.